Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below.
This position will be responsible for developing and driving Elanco’s initiative to reduce or eliminate animal testing required for commercial product release through the modernization of analytical testing methods. The incumbent will provide the necessary technical expertise to Global Quality Control and network scientists in the development of new molecular biological assays relevant to the commercial release of animal health biopharmaceuticals (vaccines, biologics, viral vaccines, viral vectors, etc.) produced by Elanco’s cGMP facilities. These development activities may be conducted at contract research laboratories as well as internal Elanco laboratories. The role will collaborate with regulatory to influence external regulations to reduce or eliminate the need for non-value added animal testing.
Responsibilities
Designs, conducts and oversees the execution of laboratory experiments including analytical method development, validation and transfer. Primary techniques are ELISA, western blotting, SDS-Page, bioassays, viral titrations, serological assay, immunofluorescence and proof of inactivation.
Utilizes protein purification and characterization methods to assist in accomplishing milestones
Interfaces with other scientists in a variety of technical disciplines including process development, formulation development, clinical operations, quality control, quality assurance, discovery, and manufacturing.
Proposes, gains support for and implements ideas from individual’s knowledge of science and technology and understanding of analytical method development process.
Proposes, evaluates and implements new technologies; independently applies basic scientific principles, performs literature searches, attends scientific meetings, and keeps abreast of literature in own field.
Effectively communicates and defends own work, orally and in writing, in the context of the company and team goals at meetings
Participate in activities such as process and analytical technology transfer, statistical process control, process technical evaluations, process quality improvements (PAT), and site technology infrastructure improvements.
Provide technical leadership to the Elanco vaccine network organization on various analytical topics, including method development and improvements, approaches to troubleshooting significant analytical technical issues, references, and regulatory initiatives.
Provide technical understanding of vaccine manufacturing control strategies for technical problem solving and implementation of analytical control strategies.
Prepares verification and validation studies in accordance with current regulatory guidance
Assists with projects involving target animal safety exemptions
Monitors and leads contract service provider relationships that support the initiative
Assists with the prioritization of projects.
Supervises and assists with the personnel training and project assignments
Minimum Requirements
Ph.D. in immunology, microbiology virology, biochemistry, analytical chemistry, veterinary sciences or animal science, with a minimum of 2 years of experience, M.S. with a minimum of 4 years of relevant experience or B.S. with at least 6 years of relevant experience.
Must possess skills and knowledge within a field such as cellular, immunological, molecular, bioanalytical and chemical test methods; for example, ELISA, qPCR, IEF, viral assays, cell-based assays, SDS-PAGE, Western Blot, DNA sequencing, microbiological methods.
Must have a thorough understanding of USDA and EMEA regulatory requirements
Skills and past experience in experimental design, technical problem solving and continuous improvement
Academic or industry experience in a laboratory setting, specifically in bacterial or viral characterization.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
